Multi-valve injection/aspiration manifold with needleless access connection

ABSTRACT

An IV manifold includes a plurality of injection/aspiration ports including a needleless access port (NAC). A check valve included in the manifold is generally located at an upstream end of the manifold. However, the check valve may alternatively be located between injection ports. An aspiration port can be formed with a second seal disposed on the side of the valve element opposite a first seal. Two-way aspiration can be provided by a valve having a cage with or without compressible characteristics to accommodate low tolerance fittings. Alternatively, two way aspiration can be provided by the NAC having a single elongate valve element including a plug at one end. The elongate valve element has properties for resiliently and sealingly biasing the plug into an aperture of the NAC. In use the Plug is mechanically displaced by insertion of a male Luer for injection or aspiration.

[0001] This application is a continuation-in-part of co-pendingApplication serial No. 09/154,939, filed on Sep. 17, 1998, which ishereby incorporated by reference in its entirety.

BACKGROUND OF THE INVENTION

[0002] 1. Field of the Invention

[0003] This invention relates generally to ports for injecting fluidsinto an intravenous (IV) line, and more specifically to injectionmanifolds including multiple injection ports.

[0004] 2. Discussion of the Prior Art

[0005] Patients are commonly injected with IV solutions which areinitially provided in a bottle or bag and dripped into the vein of thepatient through an IV line. Typically an injection port is providedalong the line and adapted to function with a syringe to permit aninjectate to be added to the IV solution. If a large quantity ofinjectate, or multiple injectates, are to be added to the IV solution,multiple ports may be required. In such a case, an injection manifoldcan be disposed in the IV line to provide multiple injection ports.

[0006] A check valve is also commonly included in the IV line where itis disposed upstream from the injection manifold. It is the purpose ofthe check valve to permit fluid flow only in the direction of thepatient. This ensures that the injectate flows downstream toward thepatient, not upstream toward the IV reservoir.

[0007] The prior art is deficient in that it does not adequately providefor check valves at locations than upstream of the ports. Doing so hasits advantages in certain applications in which the prior art fallsshort.

[0008] In the past, IV manifolds have been provided with an elongate andgenerally flat configuration in order to facilitate use of the multipleinjection ports. The flow channel through the manifold has also had thiselongate wide configuration, and consequently, has been susceptible tothe formation of air pockets, and to generally uneven flowcharacteristics. In the vicinity of the injection ports, the manifoldsof the past have also developed dead spaces where the injectate hastended to collect rather than mix with the IV solution. Other IVmanifolds have been provided with a round tube defining the flowchannel. Injection ports have been connected to this tube at a “T”junction. In this case, the flow channel has remained separate and theproblems with dead spaces in the ports have been significant.

[0009] Injection ports of the past have generally included only valveswith a single valve seal. These seals have not been capable ofwithstanding high pressure such as those sometimes associated with aninjection into an adjacent port. The resulting high back pressure hassometimes caused the valve element to deform and lodge in the lumen ofthe port, rendering the port inoperative.

[0010] In the past, the ports associated with injection manifold havenot been provided with characteristics permitting the aspiration offluids from the flow channel. This is sometimes desirable in order toremove air from the manifold or withdraw a blood sample. In these cases,a separate aspiration port has been required in addition to theinjection manifold.

[0011] Even the three valve seat system provided by t6he embodimenthaving an apertured valve element of the instant invention has somedrawbacks for certain applications. For example, this embodimentrequires relatively high pressure for both aspiration and injection.

[0012] Some injection ports have been provided with operative cageswhich mechanically open the valves. In this case a syringe having a maleLuer fitting is relied on to push the cage against the valve element inorder to open the valve. Due to wide tolerance variations in the plasticparts associated with the syringes, the male Luer fittings can sometimesextend into the injection port a distance greater than that required toopen the valve. In many of these cases, damage to the injection port hasresulted.

[0013] Although the cage and valve element embodiment of the instantinvention provides a means for permitting unimpeded aspiration, andalthough the cage of the instant invention provides for inserting avariety of male Luers without damaging the port or manifold, the cageadds a separate piece and increases the complexity of the overalldevice. With the cage embodiment, changes are also required in the portitself to accommodate the cage. For example, a large portion of thesecond seat must be removed in order to provide room for the cage.

SUMMARY OF THE INVENTION

[0014] These problems with the injection ports and manifolds of theprior art are overcome with the present invention which provides for agenerally U-shaped flow channel that extends axially of the manifold. Byrestricting the IV solution to this flow channel, the flowcharacteristics through the manifold are greatly enhanced. Importantly,there are no dead spots in the fluid flow through the manifold.Furthermore, the flow of fluid can be directed against the valve elementof the injection port to avoid dead spots around the valve. A checkvalve can be included in this manifold and disposed at one end of theelongate housing. An infusion/aspiration port is preferably disposedupstream of the other injection ports and downstream of the check valve.

[0015] Alternatively, the check valve may be located between an upstreaminjection/aspiration port and a downstream injection/aspiration port. Inthis way an injection/aspiration port may be advantageously locatedupstream of the check valve. As can be understood by those skilled inthe art, locating the check valve downstream of at least one of theinjection/aspiration ports enables either pulling IV fluid from the IVline into a syringe or reservoir of the port upstream of the check valvewithout pulling fluid from downstream of the check valve, or pulling ofinjectate from the at least one port into the IV line upstream of themanifold.

[0016] A preferred injection port is provided with two seals, a lineseal and a surface seal, which provide for low pressure and highpressure operation, respectively. When an injectate is being introducedinto an adjacent port, the resulting high back pressure is resisted bythe high pressure surface seal of the port.

[0017] In an injection port embodiment including a cage, the cage can beconfigured to be axially compressible. These compressiblecharacteristics accommodate the wide tolerance variations in the plasticparts which sometimes tend to cause a male Luer fitting to extend intothe injection port a distance greater than that necessary to open theassociated valve. By providing the cage with these compressiblecharacteristics, the tolerance variations are accommodated withoutdamaging the valve element.

[0018] Alternatively, and perhaps preferably, a needleless accessconnection (NAC) can be included in the manifold. The NAC has theadvantage of enabling the aspiration as well as the injection of fluidstherethrough. This feature is achieved with a simple and reliablestructure. In operation, a male Luer is inserted into a aperture of theNAC in order to open a NAC valve and permit aspiration or injection offluids through the NAC. As can be appreciated, the aspiration andinjection through the NAC requires very low pressures.

[0019] In one aspect, the invention includes an injection port adaptedfor use with an IV line. The port includes a housing defining a flowchannel and having an injection lumen. First portions of the housingdefine a first valve seat, while second portions of the housing define asecond valve seat. A valve element, disposed to extend transverse to theinjection lumen has properties for forming a first seal with the firstvalve seat at a first pressure, and a second seal with the second valveseat at a second pressure greater than the first pressure. The firstvalve seat, which forms part of the second valve seat, has the shape ofa continuous line, while the second valve seat has the shape of acontinuous surface.

[0020] In another aspect, the invention includes a port for injecting aninjectate into a flow channel for aspirating a fluid from the flowchannel. The port includes a housing defining the flow channel andhaving a lumen disposed in fluid communication with the flow channel.First portions of the housing define a first valve seat while secondportions of the housing define a second valve seat. A valve element hasproperties for forming a first seal with the first valve seat and asecond seal with the second valve seat when the valve element is in anatural state. The valve element has properties for opening the firstseal in response to a positive pressure in the lumen to facilitate flowof an injectate into the flow channel. The valve element also hasproperties for opening the second seal in response to a negativepressure in the lumen in order to facilitate flow of the fluid from theflow channel into the lumen of the port. The first valve seat is formedon the side of the valve element opposite the flow channel. The secondvalve seat is formed on the side of valve element opposite the firstvalve seat. This embodiment may include a post with the second sealbeing formed around the post.

[0021] In an additional aspect of the invention an injection manifoldincludes a first body member and second body member forming a housing.First portions of the housing define a flow channel adapted to receivean IV solution flowing in an IV line. Second portions of the housingdefine at least one port with an injection lumen, the port having aoutside diameter. The first portions of the housing have a width greaterthan the outside diameter of the port and define the flow channel with awidth less than the diameter of the port. The flow channel willtypically have a U-shaped configuration.

[0022] In a further aspect of the invention an injection/aspiration portincludes a housing with first portions defining a flow channel andsecond portions defining an injection/aspiration lumen. Third portionsof the housing define a valve seat around the lumen. A valve element isbiased toward the injection/aspiration lumen and forms a seal with thevalve seat. A valve cage is disposed in the lumen and adapted to bemoved by insertion of a male Luer fitting into the lumen against thevalve element to open the seal and permit two-way flow between the lumenand the flow channel. The valve cage is axially compressible toaccommodate slight variations in the size of the male Luer fitting.

[0023] These and other features and advantages of the present inventionwill be more apparent with a description of preferred embodiments andreference to the associated drawings.

Description of the Drawings

[0024]FIG. 1 is a perspective view of an arm of a patient with an IVsolution appropriately administered through an injection manifold of thepresent invention;

[0025]FIG. 2A is a perspective view of the manifold having threeinjection ports and syringes of various sizes connected to the ports;

[0026]FIG. 2B is a perspective view of an additional embodiment of themanifold having two injection ports and a NAC and syringes of varioussizes connected to the port and NAC;

[0027]FIG. 3A is an exploded view of the manifold of FIG. 2Aillustrating first and second members forming a housing, and showing theinterior of the first member and the exterior of the second member;

[0028]FIG. 3B is an exploded view of the embodiment of FIG. 2B includingthe NAC;

[0029]FIG. 3C is an exploded view of a further embodiment similar toFIG. 3A with the check valve disposed between two of the ports;

[0030]FIG. 4A is an exploded view similar to FIG. 3A but showing theinterior of the second member and the exterior of the first member;

[0031]FIG. 4B is an exploded view similar to FIG. 4A of the embodimentof FIG. 3B including the NAC;

[0032]FIG. 4C is an exploded view similar to FIG. 4B of the embodimentof FIG. 3C;

[0033]FIG. 4D is an exploded perspective view of the embodiment of FIG.3C with the check valve disposed between two ports;

[0034]FIG. 5 is a side elevation view of the manifolds illustrated inFIGS. 2A-4D;

[0035]FIG. 6 is a top plan view of the manifolds illustrated in FIG. 5;

[0036]FIG. 7A is a cross-section view taken along lines 7-7 of FIG. 5;

[0037]FIG. 7B is a cross-section view taken along lines 7-7 of FIG. 5and explicitly incorporating the NAC and the check valve, with the checkvalve disposed between two of injection ports;

[0038]FIG. 8A is an axially cross-section view taken along lines 8-8 ofFIG. 6;

[0039]FIG. 8B is an axial cross-section view taken along lines 8-8 ofFIG. 6 and explicitly showing the NAC and the check valve, with thecheck valve disposed between two of the injection ports;

[0040]FIG. 9 is a cross-section view taken along lines 9-9 of FIG. 6;

[0041]FIG. 10 is a cross-section view similar to FIG. 9 and illustratinga further embodiment of the manifold;

[0042]FIG. 11 is a radial cross-section view of an injection port takenalong lines 11-11 of FIG. 6;

[0043]FIG. 12 is a radial cross-section view of the injection port takenalong lines 12-12 12 of FIG. 6;

[0044]FIG. 13 is a cross-section view illustrating the port of FIG. 12in a high pressure configuration;

[0045]FIG. 14-16 are cross-section views similar to FIG. 12 illustratingoperation of an injection port which also has aspirationcharacteristics;

[0046]FIG. 14 is a cross-section view similar to FIG. 12 and showing afurther embodiment of the invention with a,valve in a normal state;

[0047]FIG. 15 is a cross-section view similar to FIG. 14 andillustrating the valve in an injection state;

[0048]FIG. 16 is a cross-section view similar to FIG. 14 andillustrating the valve in an aspiration state;

[0049]FIGS. 17 and 18 are cross-section views similar to FIG. 12 andillustrating a further embodiment including a mechanical cage foractuating the valve element;

[0050]FIG. 17 is a cross-section view similar to FIG. 12 and showing thevalve in a normal sealed state; FIG. 18 is a cross-section view similarto FIG. 17 and illustrating the cage in a compressed configuration withthe valve in an injection/aspiration state; and

[0051]FIG. 19 is a section view of an end of the manifold of the secondand third alternative embodiment similar to FIG. 8B.

DESCRIPTION OF THE PREFERRED EMBODIMENTS AND BEST MODE OF THE INVENTION

[0052] The arm and hand of a patient are illustrated in FIG. 1 anddesignated generally by the reference numeral 10. An IV solution 12contained in a reservoir, such as a bottle or bag 14, is appropriatelycommunicated to the patient 10 through an IV line 16. An injectionmanifold 18 of the present invention is connected in series with theline 16 and provides a site where drugs and other fluids can beinjected, typically through a syringe 21, into the IV solution in theline 16.

[0053] The manifold 18 of a preferred embodiment is illustrated ingreater detail in FIG. 2. In this view it can be seen that the manifold18 has a housing 23 with an elongate configuration, and extendsgenerally along an axis 25. The housing 23 is connected in series withthe IV line 16, for example by a pair of connectors 22 and 24, so thatthe flow channel and the IV line 16 also extends through the housing 23.

[0054] A plurality of injection ports 27, 30 and 32 can be moldedintegrally with the housing 23 and spaced along the length of thehousing 23. In FIG. 2, a 60 mm syringe 34 is connected to the port 32,while a 10 mm syringe 36 and a 5 mm syringe 38 are connected to theports 30 and 27, respectively. There will of course be situationsrequiring three syringes such as the 60 cc syringe 34 that must becoupled to the manifold 18 at the same time. This will require that theports 27, 30 and 32 be spaced sufficiently that the ports 27 and 32 areseparated by a distance equal to two times the diameter of the 60 ccsyringe 34, and the center port 30 disposed intermediate with the outerports 27 and 32.

[0055] The manifold 18 is further illustrated in the exploded views ofFIGS. 3 and 4. In these views, the housing of a preferred embodiment isillustrated to include a first housing member 41 and a second housingmember 43. The first housing member 41 has in inner side 45 illustratedin FIG. 3 and an outer side 47 illustrated in FIG. 4. Similarly, thesecond housing member 43 has an inner side 46 and an outer side 48. Fromthese views it can be seen that each of ports 27, 30 and 32 includes acylinder 50, 52 and 54, respectively, which projects from the outersurface 47 of the first housing member 41. These cylinders 50, 52 and 54in turn define lumen 56, 58 and 61, respectively, which are in fluidcommunication with the flow channel 49. The cylinders 50, 52 and 54 alsoform with the first housing member 41 a plurality of cavities 63, 65 and67, respectively, which are adapted to receive associated valve elements70, 72 and 74. The operation of these ports 27, 30 and 32 will bediscussed in greater detail below.

[0056] In this particular embodiment, a check valve 76 is provided atone end of the manifold 18. In this case, the check valve 76 is formedwith a plurality of pins 78 which extend from the inner side 45 in agenerally circular configuration. These pins 78 are adapted to receive avalve element 81. The manifold 18 is intended to be connected in the IVline 16 and oriented with the check valve 76 connected to the upstreamside of the line 16.

[0057] Perhaps best illustrated in FIG. 4 are a plurality of protrusions83, 85 and 87 which interrupt the flow channel 49 at each of theassociated ports 27, 30 and 32, respectively. These protrusions 83, 85and 87, which are also illustrated in the assembled view of FIG. 7 andthe cross-section view of FIG. 8, are of particular advantage to thepresent invention as they disrupt the flow of the IV solution 12 alongthe channel 49 and direct that flow into the associated cavities 63.With this directed fluid flow, the cavities 63, 65 and 67, andparticularly the valve elements 70, 72 and 74, are constantly washed sothat there are substantially no dead spots associated with the injectionports 27, 30 and 32. In the past, these dead spots have beenparticularly common in the concave area beneath the valve 70, 72 and 74.With the fluid flow directed specifically onto the concave side of eachelement 70, 72 and 74, the dead spots are greatly minimized. Thisdiverted flow is illustrated in greater detail in FIG. 11 where thecavity 63 and valve element 70 of the injection port 27 are washed bythe IV solution flow which is illustrated by arrows 89.

[0058] In relation to this washing effect, FIGS. 7A-B illustrate how thevalve cavities associated with ports 27, 30 and 32 have a height lessthan each of a width and a length. In this way, a flow path is formedsuch that a liquid passing through the manifold, readily impinges on anunderside of the valve elements in the cavities. Thus the structuralrelationship of height to width and length reduces stagnation. Flow isfurther enhanced by structural details in the cavities. Specifically,the portion of the cavities forming valve the valve seats and the valveelements 70, 72, 74 themselves form a concave surface on a side of thevalve elements 70, 72, 74 opposite to the valve seats.

[0059] With reference to FIG. 9, it can be seen that a preferredembodiment of the manifold 18 provides a flow channel 49 with a U-shapedconfiguration. This shape is generated by providing the inner surface,45of the first housing member 41 with a generally planar configuration.When the second housing member 43 is mated to the first housing member41, a U-shaped cavity 90 in the surface 48 automatically provides theflow channel 49 with the U-shape desired. In this particular embodiment,the generally planar inner surface of the housing member 41 makes itpossible to also provide the outer surface 47 with a planarconfiguration. This shape greatly facilitates wiping the manifold 18between the adjacent ports 27 and 30, and the ports 30 and 32.

[0060] In an alternative embodiment illustrated in FIG. 10, the flowchannel 49 is defined by the U-shaped cavity 90 formed in the firsthousing member 41, and by a second U-shaped cavity 92 formed in thesecond housing member 43. When these parts are joined, the two cavities90 and 92 provide the flow channel 49 with the shape of an oval. Theviews presented by FIGS. 9 and 10 also are best suited to illustrate themating relationship of the first housing member 41 and the secondhousing member 43. These members 41 and 43 are operatively positionedwith their respective surfaces 45 and 46 in close proximity so thatthese surfaces do not form any part of the flow channel 49. Thiscontributes greatly to the flow characteristics within the channel 49and avoids many of the air pockets and dead spots associated With thefull-width flow channels of the prior art. The second housing member 43can be fixed to the first housing member 41 in this operative positionby means of adhesive or by heat seals 94.

[0061] Operation of the injection port 27 is best described withreference to FIGS. 12 and 13. In these views, it will be noted that theport 27 includes portions 96 which define a first valve seat andportions 98 which define a second valve seat. The first valve seat 96forms a slight annulus above the valve element 70. In its normalconfiguration, the valve element 70, which has elastomeric properties,is biased by the protrusion 83 beneath the element 70 to form a sealwith the first valve seat 96.

[0062] When an injectate is introduced through one of the adjacentports, such as port 30 or 32, a relatively high pressure occurs in theflow channel 49. By operation of the check valve 76, this pressure isexerted against the underside of the valve element 70 of the port 27. Inthe manifold 18, the higher pressure will cause the valve element 70 todeform as illustrated in FIG. 13 until it comes into contact with thesecond valve seat 98 as illustrated in FIG. 13. With this second valveseat 98 providing surface contact with the valve element 70, a highpressure seal is formed without radical deformation or damage to thevalve element 70.

[0063] Under some circumstances, it is desirable to have an injectionport, such as the port 32, function not only to receive injectate intothe flow channel 49, but also to aspirate or withdraw fluid from theflow channel 49. When an injection/aspiration port, such as the port 32,is included in the manifold 18, it is preferably disposed on theupstream side of the other ports so that injectate introduced in theother ports is not aspirated from the manifold 18. Since the check valve76 is also to be positioned upstream of the ports 27-32, it is desirablethat the injection/aspiration port 32 be positioned next to the checkvalve 76.

[0064] A preferred configuration for the injection/aspiration port 32 isillustrated in FIGS. 14-16. In this embodiment, the projection 87 isconfigured with a shoulder 101 which forms a third valve seat 103, and apost extending toward the lumen 61 of the port 32. In this case, thevalve element 74 is provided with a central aperture or hole 107 whichis sized to receive the post 105. In the manner previously discussedwith reference to the FIG. 12 embodiment, a first valve seat 110 can beformed above the valve elements 74 with the third valve seat 103 formedbeneath the valve element 74. In its normal state, the port 32 ispositioned with the valve element 74 biased to form a first seal withthe first valve seat 110 and a second seal with a third valve seat 103as illustrated in FIG. 14. Under the fluid pressure of an injectate, asillustrated by an arrow 112 in FIG. 15, the valve element 74 is bentdownwardly opening the first seal at the first valve seat 110. Thesecond seal with the valve seat 103 is strengthened by this downwardpressure against the valve element 74. Nevertheless, the injectate 112flows through the first valve and into the flow channel 49.

[0065] Aspiration is accommodated by applying a suction to the lumen 61as illustrated by an arrow 114 in FIG. 16. This causes the valve element74 to raise off of the shoulder 103 which form the second valve seat.Fluid within the flow channel 49 is thereby permitted to pass betweenthe valve element 74 and the post 105 into the lumen 61. In all cases,the hole 107 in the valve element 74, and the post 105, maintain thevalve element 74 centered with respect to the valve seats 110 and 103,respectively.

[0066] A further embodiment of the injection/aspiration port 32 isillustrated in FIGS. 17 and 18. In this case, the port 32 is operatednot by fluid pressure, but rather mechanically by the force of thesyringe 38 acting upon a cage 121. In this case, the cylinder 54defining the lumen 61 is provided with an interior shoulder which facesdownwardly and prevents the cage 121 from moving upwardly within thelumen 61. In this embodiment, the cage 121 fits between the shoulder 123of the cylinder 54 and the upper surface of the valve element 74. Thecage 121 can be formed of wire or other resilient material and providedwith a configuration which is axially compressible. The advantage ofthis port 32 is that it does not rely upon fluid pressure to open, butrather the mechanical force of a male Luer fitting 123 associated withthe syringe 38.

[0067] With the tolerances accommodated in forming the Luer fitting 123and in forming the lumen 61, it can be appreciated that the syringe 38can extend a variable distance into the cylinder 54. If the cage 121 isprovided only as a rigid element, damage to the valve element 74 canresult when the male Luer fitting 123 extends too far into the lumen 61.In the illustrated embodiment, wherein the cage 121 is axiallycompressible, this great variation in distance of insertion can beaccommodated by the cage 121 so that the valve element 74 is notradically deformed. When the valve element 74 is opened by the cage 121,two-way flow through the port 32.can be accommodated as illustrated bythe arrows 125 in FIG. 18. Thus, the valve element 74 is separated fromthe valve seat 110 opening the valve to either receive injectate intothe flow channel 49 or remove fluid from the flow channel 49.

[0068]FIG. 2B illustrates a modified manifold 130. The modified manifold130 differs from the embodiment of FIG. 2A in that a port 27 has beenreplaced by a needleless access connection (NAC) 132. All other aspectsof the manifold remain the same. However, the NAC has several detailsthat are unique and important. The NAC is made up of a body portion 133having a top piece 134 thereon. The top piece has an aperture 135therethrough forming part of a conduit through the NAC body 133. The toppiece 134 is also provided with a fastening means 136. A bottom end 137of the NAC 132 is connected to the housing 23. In this embodiment, theNAC can be rigidly connected to or formed integrally with the housing23.

[0069]FIG. 3B perhaps best illustrates an aspect of the NAC bottom end137. This aspect is a grate 138 integrally formed with the bottom end137. Grate 138 provides an opening 141 through which fluid may flow. Atthe same time, grate 138 retains an elongate valve element 143 withinthe NAC 132. The elongate valve element is further retained by ashoulder 144 formed on the interior of top piece 134. In this way, theelongate valve element 143 is captured in the NAC 132 and extendsbetween the grate 138 and the top piece 134.

[0070] As can be seen from FIG. 4C, the grate 138 may be replaced by agrate means 145. In this embodiment the grate means 145 is not formedintegrally with the NAC body portion 133. Rather the grate means 145 isformed separately as a part of housing member 43. In this way, it can beappreciated that the elongate valve element 143 will be captured in theNAC 132 when the housing members 41 and 43 are assembled together.Importantly, grate means 145 still provides an opening at a bottom endof the NAC 132. This opening is provided by slot 147 and other structurethat permits fluid to flow in and out of a bottom end 137 of NAC 132.

[0071] As can be seen in the Figures, the NAC has a diameter of widthgreater than the other injection valves, yet narrower than the housingof the manifold 132. The bottom end 137 of the NAC 132 is rigidlyconnected to the manifold housing. Furthermore, the bottom end 137 ofthe NAC 132 has an opening for placing the conduit or interior of theNAC 132 in fluid communication with the flow channel 49 of the manifold132

[0072] A second alternative embodiment or modified manifold 152 isperhaps best illustrated in FIG. 3C. The second modified manifold 152 isdifferent from the manifold 18 in that the locations of the injectionport 32 and the check valve 76 have been interchanged. All other aspectsremain substantially the same. However, additional flow channel 154 bestillustrated in FIG. 4A and FIG. 19 have a different and significantrelationship to other elements of the invention in this embodiment. Theadditional flow channel 154 of the previously described. embodimentsnormally defines a flow between an IV fluid inlet and a first port 32.However, in the second modified manifold 152 the additional flow channel154 now defines a flow path for the IV fluid between the injection port32 and flow channel 49. In this case additional flow channel 154 is indirect fluid communication with flow channel 49.

[0073]FIG. 19 illustrates how the second modified manifoldadvantageously functions. As shown, injection flow through port 32 andindicated by arrows 156 can be caused by a net negative pressure in theupstream portion of the IV line. Of course, if the net negative pressureis in a downstream portion of the IV line relative to the check valve76, then flow 156 will move through the check valve 76 and downstream.However, as can be appreciated, by manipulating the pressure upstream ofthe manifold in the IV line between a negative net pressure and apositive net pressure, the flow may be alternated between an injectionflow 156 and a downstream through flow 158. By thus cycling negative andpositive pressures upstream in the IV line, a repeated draw of fluidfrom a reservoir connected to port 32 and a forcing through of the fluidthrough the manifold may be achieved. Of course, a single cycle or ahalf cycle may be implemented as well.

[0074] A third alternative embodiment or alternatively modified manifold165 is depicted in FIG. 5. As shown in dashed lines the manifold of thisembodiment incorporates the NAC 132 in place of port 27 and interchangedlocations of injection port 32 and the check valve 76. All other aspectsof the manifold are substantially the same.

[0075]FIG. 7B is a sectional view along lines 7-7 of FIG. 5 andexplicitly showing the third alternatively modified manifold 165.Likewise, FIG. 8B is a sectional view taken along lines 8-8 of FIG. 6and also shows the third alternatively modified manifold 165.

[0076]FIG. 8B best illustrates the elongate valve element 143 of thefirst and third alternative embodiments. The elongate valve element 143has a plug 170 at its upper end and an elastomeric shaft 172 extendingdownwardly and engaging the grate 138. As can be appreciated, theelastomeric shaft resiliently biases the plug 170 into the aperture 135of the NAC 132.

[0077] In use, when a male Luer is forced into the aperture 135 of theNAC and seals the NAC against fluid passage or reflux in and out of thetop of the NAC. The plug 170 is resiliently displaced downwardly intothe NAC 132. The elastomeric shaft 172 cants and permits thisdisplacement, and fluid communication is thereby established between theLuer tip and the NAC. The elastomeric shaft 172 may include structuralfeatures that enhance canting such as, for example, recesses in theelastomeric shaft 172. It can also be appreciated that the height of theNAC and the resiliency of the elongate valve element 143 accommodate awide range of male Luer lengths without harming or adversely affectingthe manifold.

[0078] The NAC of the instant invention has an advantage over many ofthe injection ports described above in that the NAC may be used foraspiration as well as for injection of fluids therethrough. Furthermore,the NAC is capable of operating at lower pressures. For example, the NACmay be operated at pressures of 1.5 psi or less depending on otherrelative pressures in the system. On the other hand the injection portsof the previously described embodiments operate at higher pressures.That is, for example, in the range of 2-6 psi. As can be appreciated bythose skilled in the art the NAC therefore can be appropriately used toinject fluids therethrough from an IV bottle or bag source.

[0079] It will be appreciated that many variations of these embodimentswill now be apparent to those skilled in the art. Certainly, theconfiguration of the flow channel 49 can be varied widely to accommodateand improve fluid flow through the manifold 18. Also, the shape of theprojections 83, 85 and 87 can be varied considerably as long as thefluid flow is directed into the cavities containing the valve elements.Other embodiments providing multiple valve seats to accommodate high andlow pressures will also be apparent. In addition, other portsfacilitating aspiration from the flow channel 49 will also be apparentto either provide two-way fluid communication or alternatively tootherwise direct the fluid flow as illustrated in the Figures.

[0080] Based on these and many other variation which will now beapparent, one is cautioned not to determine the extent of the conceptonly with reference to the disclosed and illustrated embodiments, butrather to determine the scope of the invention only with reference tothe following claims.

We claim:
 1. An injection port adapted for use with an intravenous line,comprising: a housing defining a flow channel and having an injectionlumen extending in fluid communication with the flow channel; firstportions of the housing defining a first valve seat around the injectionlumen; second portions of the housing defining a second valve seataround the injection lumen; a valve element disposed to extendtransverse to the injection lumen; the valve element having propertiesfor forming a first seal with the first valve seat at a first pressure;the valve element having properties for forming a second seal with thesecond valve seat in response to a second pressure greater than thefirst pressure of the fluid in the flow channel, and the valve elementhaving properties for forming an open configuration between said lumenand said flow channel in response to a third pressure in said lumengreater than one of said first pressure and said second pressure.
 2. Theinjection port recited in claim 1, further comprising: third portions ofthe housing defining a third valve seat on the side of the valve elementopposite the first and second valve seats; and the valve element havingproperties for forming a third seal with the third valve seat.
 3. Theinjection port recited in claim 2, wherein the valve element hasproperties for opening at least the first seal for said openconfiguration under the pressure of an injectate in the injection lumento create a flow path around the valve element between the injectionlumen and the flow channel; and the valve element has properties foropening the third seal in response to a partial vacuum in the injectionlumen to aspirate a portion of the fluid in the flow channel through anaperture in the valve element and into the injection lumen.
 4. Aninjection manifold adapted to be disposed in an intravenous lineextending from an intravenous reservoir to a patient, the manifoldcomprising: a first body member; a second body member forming with thefirst body member a housing; first portions of the housing defining aflow channel to receive the IV solution flowing in the IV line; secondportions of the housing defining at least one port with an injectionlumen, the port having an outside diameter; third portions of thehousing defining at least one cavity interconnecting in fluidcommunication said flow channel and said at least one port, said atleast one cavity having a plurality of valve seats; and the firstportions of the housing having a width greater than a width of thecavity and the width of the cavity being greater than the diameter ofthe port.
 5. The injection manifold recited in claim 4, wherein saidthird portion defines said cavity having a height less than each of awidth and a length of said cavity such that the flow of a liquid passingthrough the manifold readily impinges on an underside of a valve elementin said cavity and thereby reduces stagnation.
 6. The injection manifoldrecited in claim 5, wherein said third portion and said valve elementform a concave surface on a side of the valve element opposite from thevalve seats.
 7. An injection/aspiration port adapted for operation witha male Luer fitting, comprising: a housing; first portions of thehousing defining a flow channel; second portions of the housing definingan injection/aspiration lumen; third portions of the housing defining avalve seat around the injection/aspiration lumen; a valve element biasedtoward the injection/aspiration lumen and forming a seal with the valveseat; a valve cage disposed in the lumen and adapted to be moved byinsertion of the male Luer fitting into the lumen against the valveelement to open the seal and permit two-way flow between the lumen andthe flow channel; a first body member comprising the second portions andthird portions and defining the lumen and the valve seat, the lumenhaving an enlarged portion defining a shoulder against which the valvecage is biased when no male Luer is inserted; and a second body membercomprising the first portions and forming the housing with the firstbody member, said second body member including portions contacting thevalve element on the side of the valve element opposite the valve seatto bias the valve element against the valve seat to form the seal. 8.The injection/aspiration port recited in claim 7, wherein the valve cageis resilient, is biased to an expanded state, and is adapted to becompressed by the insertion of the male Luer, wherein the cage hasproperties for moving the valve only a small distance in response to themale Luer being inserted to any of a range of predetermined depthsgreater than said small distance.
 9. A manifold for placement in an IVline and for sealingly connecting said IV line between an upstreamportion and a downstream portion thereof, said manifold comprising: ahousing defining flow volume including a volume in a flow channel; aplurality of fluid injection ports in said housing in fluidiccommunication with said flow channel; at least one of the injectionports having at least one valve, said at least one valve having a firstvalve seat, a second valve seat, and a valve element; said valve elementhaving properties that cause the valve element to engage said firstvalve seat at a first fluid pressure and to engage said second valveseat at a second fluid pressure; and said plurality of fluid injectionports further comprising at least another injection port comprising aninjection and aspiration port in the form of a needleless accessconnector (NAC); and at least one check valve in the flow volume forlimiting flow in at least one direction through the manifold.
 10. Themanifold of claim 9, wherein said check valve is located upstream ofsaid at least one fluid injection port.
 11. The manifold of claim 9,further comprising: said check valve located downstream of said at leastone fluid injection port, wherein: suctioning upstream of said fluidinjection valve pulls fluid from a reservoir feeding the fluid injectionport and into the manifold, and forcing IV fluid into the manifold fromupstream closes the fluid injection valve and opens the check valve;whereby repetitions of said suctioning and forcing cause a cyclicalpumping of the fluid from said reservoir feeding the fluid injectionport.
 12. The manifold of claim 9, further comprising: said check valvelocated downstream of said at least one fluid injection port, whereinsuctioning from said at least one fluid injection port pulls fluid fromupstream in the IV line, through a portion of the manifold, and into areservoir connected to the at least one port, and forcing fluid throughsaid at least one port into the manifold from the reservoir sends saidfluid downstream through said check valve; whereby repetitions of saidsuctioning and forcing cause a cyclical pumping of the fluid fromupstream in said IV line into said reservoir and downstream through saidcheck valve.
 13. The manifold of claim 9, said needleless accessconnector comprising: a body having an end piece at a first end of saidbody, said end piece having an aperture therethrough, said body forminga conduit, said conduit extending in fluid communication with saidaperture, an opening in a second end of said body, said second end ofsaid body connected to said manifold with said conduit in fluidcommunication through said opening with said flow channel; and anelongate valve element disposed in said conduit and comprising: a plugat one end sealingly disposed in said aperture to prevent reflux throughthe aperture, and an elastomeric shaft to resiliently bias the plug intosaid aperture.
 14. The manifold of claim 13, wherein said needlelessaccess connector is connected to the manifold downstream of the checkvalve.
 15. The manifold of claim 9, wherein said at least one fluidinjection port is an injection/aspiration port and is the next portdownstream of the check valve.
 16. A manifold for placement in an IVline in order to facilitate injecting fluids into and withdrawing fluidsfrom said IV line, said manifold comprising: an upstream connection atan upstream end, a downstream connection at a downstream end; a firstbody member between said upstream connection and said downstreamconnection and defining a first portion of a housing; a second bodymember defining a plurality of fluid injection ports and a secondportion of said housing; a plurality of cavities formed by said firstportion and said second portion between said fluid injection ports andsaid first portion of said housing; at least one valve in one of saidcavities, said valve comprising at least one valve member, said valvemember dividing said cavity into first and second parts generallyadjacent to said first and second portions of said housing respectively;said housing forming a fluidic communication therethrough between saidupstream connection and said downstream connection; said first housingmember and said second housing member defining at least one flow channelbetween said first housing member and said second housing member andfluidically connecting said cavities; and said manifold defining a flowvolume comprising a volume in said upstream connection, a volume in saiddownstream connection, a volume in said second part of said cavities,and a volume defined by said flow channel; wherein all of the flowvolume is substantially in a flow path such that substantially none ofthe flow volume becomes stagnant.
 17. The manifold of claim 16, furthercomprising a needleless access port (NAC) connected to the housing inaddition to said plurality of ports.
 18. The manifold of claim 16,further comprising a check valve in said housing between at least oneupstream and one downstream fluid injection port.
 19. The manifold ofclaim 17, further comprising a check valve in said housing between theupstream connection and at least one downstream fluid injection port.20. A needleless access connection (NAC) in combination with a manifoldhaving at least one injection port and adapted for use with anintravenous line, said combination comprising: a housing with anupstream connection and a downstream connection, said housing having afirst portion defining a flow channel between said upstream connectionand said downstream connection; said housing comprising a second portionintegrally providing said NAC, said NAC having structure defining aninjection and aspiration conduit, said second portion further providingan injection and aspiration aperture at one end of said NAC in fluidcommunication with the conduit; said housing comprising a third portionintegrally defining a grate having at least one opening at another endof said NAC and extending in fluid communication with said conduit andsaid flow channel for fluid injection into and aspiration from said flowchannel; an elongate valve element disposed in said second portion ofsaid housing and naturally biased into engagement with the injection andaspiration aperture; the elongate valve element having properties fornaturally forming a first seal with the injection aperture; and thevalve element having properties for moving out of said aperture inresponse to insertion of a male Luer into said aperture, and forresiliently moving back into said aperture of said NAC when said maleLuer is removed; and said housing further comprising said at least oneinjection port in fluid communication with said flow channel.
 21. Thecombination of claim 20, wherein said elongate valve element disposed insaid second portion is also in abutting relation to said third portion.22. An injection manifold adapted to be disposed in an intravenous lineextending from an intravenous reservoir to a patient, the manifoldcomprising: a first body member; a second body member forming with thefirst body member a housing; first portions of the housing defining aflow channel to receive the IV solution flowing in the IV line; secondportions of the housing defining at least one injection port with aninjection lumen extending in fluid communication with said flow channel;and third portions of the housing defining at least one injection andaspiration needleless access connection (NAC), said NAC having a housingdefining a conduit in fluid communication with said flow channel at aproximal end and having a plugged aperture at a distal end.
 23. Themanifold of claim 22, further comprising: said at least on injectionport having a first outside diameter; said at least one NAC having atleast a second outside diameter; and the first portions of the housinghaving a width greater than the second diameter, and the second diameterhaving a width greater than the first diameter.